HVTN PIF: FAQ’s
A. Questions Concerning Sub-awards
A.1 Will HVTN issue separate sub-awards to our site for 505 and PIF?
Yes, because the funds are restricted in our NOA for PIF Funds, HVTN 503,
or HVTN 505, therefore we do need issue separate sub-award agreements for
each. At this point, 505 is the only protocol for which we will issue a sub-
award separate form the overall PIF sub-award.
A.2 Will sub-awards be amended and budgets increased if additional protocols
or protocol amendments open during the year?
Yes, the sub-awards will be amended if your site is selected to participate in a new
A.3. Will sub-awards be amended and budgets decreased if we don't meet our slot
enrollment? What if a protocol is delayed?
Core has a vested interest in assuring that our CRSs are successful, and we recognize that
sites cannot easily hire and terminate people on the basis of transitory changes in protocol
start dates or enrollment. One of the reasons for moving to the revised PIF model was to
provide you the predictability in your budgets – and therefore in your staffing – that was
lacking for many sites in the previous model. We will not want to sabotage this principal
for the sake of minor changes in enrolment or protocol start dates.
With that said, only in the case of major changes in the enrollment schedule or protocol
schedule would we anticipate making an adjustment. So what is a “major” change?
While hard to predict in advance, something like the PAVE 100 trial being cancelled, or
503 stopping enrollment would clearly qualify as a major change. A site that under-
enrolls by a handful of people would not be a major change. Obviously, this leaves a
large middle ground – and it is in that middle ground where we will work with you to
assure minimal disruption to your site.
B. Questions Concerning the Template
B.1. Will we have to complete the templates for each protocol?
No, it will not be necessary to complete the templates. Over the past three-plus years of
doing protocol funding on the template model, Core has accumulated the assumptions
from your sites for the costs for performing various parts of protocols. Based upon these
date we will estimate the total annual costs of performing various protocols for the
projected enrollment at your site and provide you with the expected budget for the
B.2. Can we see the template upon which our budget projections are based?
We will be happy to share these data with you.
B.3. Will we be able to update our template assumptions and budget during the
At this time we do not anticipate any need to update the template assumptions during the
annual grant cycle. Sites will have the opportunity prior to the start of each grant cycle to
provide HVTN Core with updated metrics for the templates. It is expected that any
possible increases in salaries for personnel would be included in your detailed budgets
submitted for PIF Funding. In general, we anticipate that budgets would only need to be
updated to accommodate additional slots or protocols.
C. Questions Concerning Invoices
C.1. Will we be required to complete invoices with visit information included, as
in the current PIF model?
No, you will no longer need to include visit information. Since all of the sub-award
agreements are now cost reimbursable, the invoices should include only costs incurred
and approved in your detailed budgets submitted.
C.2. What types of invoices will you are expecting?
We will expect the standard grant-related invoices from your institution’s accounting
office: i.e., Institutions’ standard invoice, current costs, cumulative costs and sub-
C.3. What costs are acceptable? Are there any unacceptable costs (i.e. event costs,
advertising or outreach materials, room rental)?
Allowable costs include personnel/fringe, supplies, and other costs directly associated
with the protocol implementation. As these are NIH funds, NIH policies regarding
allowable and unallowable expenditures apply. Also, included in your PIF sub-award is
$12,500 specifically earmarked for community education activities.
D. Questions Concerning “Surplus” Funds, Carry-over, Etc.
D.1. Will sites be able to keep the balance of funds unspent at the end of the grant
As the sub-awards are cost reimbursable, your institution can only bill the
HVTN for costs actually incurred. Hence, unspent funds will remain with
HVTN, but they should be available to be reallocated in the next grant cycle
in new sub-awards, should you require these funds going forward. The sub-
awards for the next annual grant cycle will be issued based on the expected
activity level at your site for that grant cycle. In the event that you expect a
major decrease in PIF activity during the new grant cycle, we would work
with you to develop appropriate solutions for the short fall, including requests
for carry-over of funds.
D.2. Under the previous PIF, fixed-price PIF model, if we were able to
do things more efficiently during one time period, we were able to
“squirrel” monies away that helped us during the lean times. It seems
like we will be unable to do that under the new, cost-reimbursable model
– is that correct?
Yes- that is correct. However, we believe that barring near-catastrophic
occurrences (such as the cancelling of the PAVE trial and the cessation of
enrollment in Phambili), the current cost-reimbursable model will protect sites
better during “down” times and therefore reduce the need to develop a “rainy
day” fund. As indicated in the response to A.3, above, we will work with
your site to minimize the disruptions to your site. Also – see response to
question D.3, below.
D.3. If we could enroll more participants than we were originally
allocated – and upon which the annual PIF budget was based - how do we
get compensated for those extra enrollees....especially if we cannot charge
any more expenses to wipe out/spend down the budget for the excess? In
other words, if we are already covering all our costs, there seems to be no
incentives for taking on more slots, as there was in the previous model.
While sites will only be able to submit invoices for costs actually incurred, we
will be happy to work with sites that feel they can take on more slots to figure
out innovative ways of recognizing and rewarding their enhanced efficiency;
this might include supporting increased staff levels commensurate with the
increase in enrollment, or other measures that are mutually agreed upon.